Apparatus and method for deploying a surgical preparation

ABSTRACT

A device used for applying an antiseptic preparation to a surgical site of a patient prior to surgery outside of an operating theater. A loose-fitting bag is provided which encloses the surgical site by securing the open end(s) to the patient by closing means. A high friction scrub surface is provided in the bag. A method and apparatus are also provided for releasing antiseptic into the interior of the bag. The method provides that the surgical site can be scrubbed within the bag so as to properly prepare the skin for surgery. A temperature indicator for the antiseptic preparation is also provided.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation in part of application Ser. No.14/312,498, filed Jun. 23, 2014, which is a continuation in part ofapplication Ser. No. 13/199,343 filed Aug. 26, 2011, now U.S. Pat. No.8,758,310, which is a continuation in part of application Ser. No.11/602,542 filed Nov. 21, 2006, now U.S. Pat. No. 8,403,898.

FIELD OF THE INVENTION

This present invention relates to a method to an apparatus and methodfor applying antiseptic prior to surgery.

BACKGROUND OF THE INVENTION

Surgical site infections are frequently caused by bacteria commonlyfound on the surface of the skin. Since 1867, when Joseph Listerdiscovered the link between microbes and patient mortality afteroperations, he coined the term “antiseptic” after discovering thatcertain surgical preparations could be applied before surgery toeliminate bacteria. Practitioners have used aseptic techniques to reducepost-operative infections ever since.

In order to reduce bacteria, antiseptics are used prior to conductingthe surgery to clean and disinfect the surgical site. Types ofantiseptics include alcohols, iodine or iodine-containing compounds andchlorhexidine gluconate among others. There are two primary types ofiodine-containing compounds, tincture of iodine, and iodophors. Tinctureof iodine is an alcohol solution and was one of the first antisepticsused. However, iodophors are more commonly used today to prepare asurgical site for surgery.

The most common aseptic technique for sterilizing a surgical siterequires application of an antiseptic solution immediately prior to thesurgical procedure in the sterile operating theater after the patienthas been anesthetized. When performing surgery to the extremities, i.e.,leg or arm, the entire extremity is typically cleaned with theantiseptic solution. A sponge is immersed in the antiseptic solution,then applied to an area of the extremity with a scrubbing action andthen discarded. A new sponge is immersed into the antiseptic solutionand applied to a different area of the extremity. This process is thenrepeated until the entire area has been scrubbed. The scrubbing actionphysically dislodges bacterial colonies. Once the scrubbing iscompleted, another antiseptic solution is reapplied with a sponge in apainting action using a new sponge with each repeated application. Afterthis procedure the surgical personnel must wait at least five to sevenminutes before beginning the surgical procedure. The delay is requiredto allow the antiseptic solution to disinfect the surgical site.

There are several problems with the prior art procedure for disinfectinga surgical site. During the application of the antiseptic solution tothe extremity, numerous sponges are required to be used and discarded,thus creating waste that must be handled and properly discarded. Thereis also a possibility that the surgical site will not be completelycovered, thus creating a potential for bacteria and other contaminantsremaining during surgery and serving as a potential source forpost-surgical infection. The application of the antiseptic solution isprone to splashing and uncontrolled spills. Excess antiseptic solutionspills creating a potential safety hazard and a potential for infection.

The prior art procedure for applying the antiseptic solution is alsocostly and time consuming. Operating theaters are expensive to maintainand operate. The time that the antiseptic solution takes to be effectivecosts the patient and the hospital a significant amount of money. Thedelay also slows the throughput of the operating theater, therebyraising the cost of the procedure to the hospital and the operatingstaff.

The prior art procedure puts the patient at an increased risk ofmorbidity and mortality by increasing the amount of time the patient isunder anesthesia.

The current invention provides a device and method for applying anantiseptic solution to a surgical site prior to surgery, but outside theoperating theater thus reducing anesthesia time along with operatingroom time and cost. The invention also contains the spills and reduceswaste. Since the application of the antiseptic can be accomplishedoutside the operating theater, additional time and care can be used inapplying the antiseptic, thereby reducing post-surgical infection.

Various prior art devices and methods have been used in the past tocover a wound, protect a wound site, or apply medicine to a wound site.But none of the prior art has been used to streamline application of asurgical antiseptic prior to surgery.

For example, U.S. Pat. No. 2,661,739 to Caskey discloses a casing whichis made from elastic material to fit against an extremity to hold anabsorbent material against a wound. The casing is surrounded by a fabricjacket to hold the casing and absorbent material in place and excludecontamination from the environment. However, the casing is onlydisclosed to be used after a wound has occurred and it does not discloseusing the device to pre-treat an area prior to surgery. Additionally, itdoes not allow for the scrubbing of medicine against the skin throughthe device.

U.S. Pat. No. 6,992,233 to Drake, et al. discloses a delivery system fora flowable medicine to a wound in a confined area. Flowable medicine iscontained in a strip which is adhesively applied to the skin such thatthe medicine is delivered to the wound. The flowable medicine isreleased when removable seal is removed. Drake does not disclose usingthe device for application of medicine prior to a wound occurring or toa large area of the body. It is limited to the area covered by thestrip. Drake also does not disclose scrubbing the medicine against theskin through the device.

U.S. Pat. No. 6,664,434 to Cominsky discloses using a sealed bag arounda wound to contain bodily fluids. The device includes an absorbent layerto absorb the bodily fluids exuding from a wound. It does not discloseusing the bag prior to the wound or introduction of an antiseptic fluidwithin the bag. It also does not disclose the scrubbing of an antisepticthrough the device.

The prior art fails to disclose or suggest a surgical solutionapplication for preparing a patent's skin prior to surgery. Therefore,it is desirable to have a device and method for facilitating applicationof antiseptic solution in a non-sterile environment.

SUMMARY

A surgical preparation solution applicator is described for preparing apatient's skin for surgery prior to entering the surgical theater. Morespecifically, a device and method for facilitating application ofantiseptic solution to a surgical site in a non-sterile environment isdescribed.

The applicator, in one embodiment, includes a bag which is sealed onthree sides and open on a fourth side. A resilient seal gasket isaffixed to the open end of the applicator bag. The gasket fits snugglyaround the patient's body forming a seal between the interior of the bagand patient's body. An antiseptic solution is then introduced into theapplication bag through either a port in the application bag, a solutiondeployment pouch within the application bag or through an openingbetween the gasket and the patient's body. The gasket prevents therelease of the antiseptic until removed.

The solution deployment pouch releases antiseptic into the bag once thegasket is secured. The pouch can take the form of a capsule in ductedcommunication with the application bag which is filled with theantiseptic solution. Other embodiments include one or more ports and/orone or more solution deployment pouches.

In another embodiment, the applicator bag employs other closing means toseal the open end of the application bag securely against the patient'sbody. This closing means can include but is not limited to a pressureinflatable cuff, a tourniquet, or a pressure strap fixed with a buckleor Velcro® closure.

In another embodiment, the application bag is open on two ends having aresilient seal gasket fixed at each end. In this embodiment, thepatient's body is inserted through the seal gaskets at both open ends ofthe application bag.

In another embodiment, the application bag is suited well for use on arelatively flat area of the body, such as the back or abdomen. In thisembodiment, the open end of the bag is secured to the patient with adisk-like adhesive strip. The adhesive strip temporarily adheres to thepatient's body during the procedure and acts as a seal between thepatient's body and the interior of the bag. After the adhesive isadhered to the patient's body, the antiseptic solution is releasedinside the application bag, either through a port or by a solutiondeployment pouch located inside the application bag.

At all places other than the seal gasket, the application bag isloose-fitting around the patient's body to allow the user to manipulatethe bag freely and completely apply antiseptic around the body partbeing treated without breaking the seal of the gasket.

In the preferred embodiment, the application bag is used to disinfectthe surgical site before the patient has undergone use of anesthesia.Because the patient is awake, the temperature of the antiseptic solutionmay be uncomfortable to the patient and increase surgery anxiety in thepatient. For this reason, the invention further provides an inexpensivemechanism to monitor the temperature of the antiseptic solution prior toapplication to the patient. Matching the temperature of the antisepticsolution to the patient aids in reducing pre-surgery anxiety of thepatient and therefore a more efficient application of the antisepticsolution.

In yet another preferred embodiment, sterile sponges or other devicesused to apply the antiseptic solution to the body can be contained insealed pouches secured to the inside of the application bag or insidethe antiseptic pouch. When the antiseptic is deployed within the bag,the sterile sponges are used to apply the bag and then discarded withthe bag prior to surgery.

After this process has been completed, the application bag contains theantiseptic and prevents outside bacteria and contaminants fromcontacting the treated area. The application bag is designed to remainin place until the patient is positioned in the operating theater. Theapplication bag is removed immediately prior to surgery.

In another embodiment, the application bag is suited well for use on anextremity, preferably a leg. In this embodiment, the application bag isgenerally shaped to fit around the extremity. The application bag issecured to the extremity with any of, but not limited to, theaforementioned securing means. The application bag further has aplurality of holes, preferably at the anterior knee area and both sidesof the ankle to accommodate the attachment of a scrub brush. Theapplication bag has an antiseptic insertion means that includes, but isnot limited to, the aforementioned antiseptic means.

The scrub brush includes a brush and a collapsible handle connected tothe brush. The brush includes bristles attached to a scrubbing surface.The brush is attached to the inside surface of the application bag atone of the plurality of holes. The collapsible handle is connected tothe brush protruding through the application bag allowing a user to movethe scrub brush without the user contacting the patient's skin.

In another embodiment, the application bag is comprised of tworeleasable halves connected to a resilient seal gasket. In thisembodiment, the patient's extremity is inserted through the gasket andpositioned upon a first half of the application bag. The second half ofthe application bag is then aligned with the first half of theapplication bag. The two halves of the application bag are releasablyaffixed to each other proximate the perimeter of each half using commonin the art means such as releasable adhesive or a resealable zipperconnection. An antiseptic solution is then introduced into theapplication bag through either a port in the application bag, a solutiondeployment pouch within the application bag or through an openingbetween the gasket and the patient's body. Removal of the applicationbag is accomplished by peeling away the first half of the bag from thesecond half of the bag using a tab extending from either or both halvesof the bag.

BRIEF DESCRIPTION OF THE DRAWINGS

In the detailed description of the preferred embodiments presentedbelow, reference is made to the accompanying drawings.

FIG. 1A is a perspective view of an embodiment of the invention showingthe use of a flat neoprene gasket seal.

FIG. 1B is a cross sectional view of a preferred embodiment offill/drain port.

FIG. 2 is a perspective view of a preferred embodiment of the inventionshowing an alternate closing means.

FIG. 3A is cross sectional view of a preferred embodiment of anantiseptic pouch attached to the interior of the application bag.

FIG. 3B is a cross sectional view of a preferred embodiment of theinvention showing an antiseptic capsule attached to the interior of theapplication bag.

FIG. 3C is a perspective view of a puncturing device used in a preferredembodiment of the invention.

FIG. 4 is a perspective view of a preferred embodiment of the inventionshowing an alternate closing means.

FIG. 5 is a perspective view of a preferred embodiment of the inventiondisclosed.

FIG. 6 is a perspective view of a preferred embodiment of the inventionshowing the use of two closing means.

FIG. 7 is a perspective view of a preferred embodiment of the inventionshowing two closing means.

FIG. 8 is a plane view a preferred embodiment of the invention.

FIG. 9 is a side view of a preferred embodiment of the invention.

FIG. 10A is a side view of a preferred embodiment.

FIG. 10B is an end view of a preferred embodiment.

FIG. 10C is a partial section view of a preferred embodiment.

FIG. 10D is a detail top view of a preferred embodiment.

FIG. 11A is a perspective view of a scrub brush of a preferredembodiment of the invention.

FIG. 11B is a side view of a scrub brush of a preferred embodiment ofthe invention.

FIG. 11C is a detail view of a connection means of a scrub brush of apreferred embodiment of the invention.

FIG. 11D is an end view of a scrub brush of a preferred embodiment ofthe invention.

FIG. 12A is a perspective view of a preferred embodiment showing tworesealable halves separated.

FIG. 12B is a perspective view of a preferred embodiment showing tworesealable halves joined.

FIG. 13 is a flow chart of steps involved in the use of a preferredembodiment.

DETAILED DESCRIPTION

FIG. 1A shows a preferred embodiment of solution applicator 100.Solution applicator 100 includes application bag 110. In the preferredembodiment, application bag 110 is made of HDPE (high densitypolyethylene) which is typically translucent, but not fully transparent.In other embodiments, the application bag can be made out of LDPE (lowdensity polyethylene) and can be quite clear, but still not totallytransparent. In other embodiments, LLDP (linear low densitypolyethylene) can be employed where a higher structural rigidity isrequired by the cleaning process. Other flexible sheeting can be used solong as it is inert with respect to the antiseptic solution.

In another preferred embodiment, the interior and/or exterior of theapplication bag can be textured to increase the effectiveness of theapplication of the antiseptic to the patient. If on the exterior of theapplication bag, the purpose of the texturing is to increase frictionbetween the hands of the user and the exterior of the application bag toaid in manipulation of the application bag during use. If on theinterior of the application bag, the textured surface is useful inscrubbing the surgical site to remove bacterial colonies. Examples oftextures can include raised ribs, chevron patterns, diamond patterns orrandom “crinkling.” Other plastics can be used if complete transparencyis required for various cleaning processes. In other embodiments, theapplication bag can be color coded to indicate different sizes,different antiseptics contained within the bag or the proper operatingtheater for the patient.

In a preferred embodiment, application bag 110 can be formed from twoidentical or nearly-identical sized sheets. Both sheets will have thesame or nearly the same shape. In a preferred embodiment, the two sheetsare rectangular. All of the sides but one are sealed or fused by anadhesive or heat welding as known in the art, leaving the remaining sideopen. The flat format of the completed application bag increases theease of storage and/or deployment of the bag from a roll or cardboardbox as known in the art. The shape also promotes economy of manufacture.

In another preferred embodiment, application bag 110 can be formed by aflexible tubular extrusion of plastic. After manufacture, the tube canthen be cut to length. After being cut, one end is sealed or fused byknown inductive welding means leaving the other end open. Otherpreferred embodiments can include frustroconical shapes, invertedfrustroconical shapes and generally spherical shapes.

Different parts of the body can be decontaminated. In FIG. 1A, patient'sappendage 150 is shown surrounded by solution applicator 100. Thedimensions of the application bag vary depending on the part of the bodybeing decontaminated. Application bag 110 should fit loosely around thebody part placed inside application bag 110.

In the preferred embodiment, the general circumference of applicationbag 110 is at least 2 inches larger than the part of the body beingdecontaminated. The width of application bag 110 in a preferredembodiment is usually between 2 inches and 40 inches. In the preferredembodiment, the general length of the application bag is at least 2inches longer than the part of the body being placed in application bag110. The length of application bag 110 in a preferred embodiment wouldbe between 2 inches and 60 inches. The application bag should also allowfor complete articulation of any joint surrounded in order to allow forcomplete coverage by the antiseptic solution.

In a preferred embodiment, application bag 110 also includes fill/drainport 140. Fill/drain port 140 allows for deployment of the antisepticsolution into the application bag and draining of excess antiseptic fromthe application bag. Fill/drain port 140 is located generally in aposition to allow for deployment of the antiseptic solution to cover theextremity. FIG. 1B is an expanded view of a preferred embodiment offill/drain port 140. Fill/drain port 140 includes lid 180. Lid 180 sealsopening in application bag 110. Lid 180 includes four parts, cap 188,threaded section 185, flexible gasket 182 and port ring 170. Cap 188 isof such minimum height that it can be easily grasped to open fill/drainport 140. Threaded section 185 width can vary in size between ¼ inch and4 inches. Threaded section 185 is threaded to match port ring 170.

Port ring 170 is attached to opening in application bag 110 by a knownadhesive or heat welding. Port ring 170 is threaded to receive threadedsection 185. Port ring 170 is approximately the same depth as thethreaded section 185. In the preferred embodiment the depth is betweenabout ¼ of an inch to about 3 inches. A flexible gasket 182 is providedto seal the lid against the port ring. When lid 180 is threaded intoport ring 170, bottom of lid 180 fits flush and seals against of portring 170.

Fill/drain port 140 can be constructed from any commercially availableplastic, including but not limited to polypropylene, polyethylene, orpolystyrene. In other embodiments, the fill/drain port can be fittedwith a quick release mechanism for removal of the antiseptic with a pumpthrough a hose and connection fitting. Other non-threaded resealable capand base configurations will also suffice.

Attached to open end of application bag 110 is gasket 120. Open end ofapplication bag 110 is affixed to gasket 120 through a known adhesive orheat welding. Gasket 120 can be manufactured from synthetic rubber, suchas neoprene, or a resilient plastic polymer. The gasket color can becoded to indicate the size and/or shape of the bag making for easy anderror free deployment of the antiseptic solution.

Gasket 120 has hole 130 in the relative center of gasket 120. Patient'sappendage 150 is inserted through hole 130 and into application bag 110.In the preferred embodiment, diameter of hole 130 ranges between about 1inch and 15 inches. However, those skilled in the art will recognizethat other sizes can be provided to accommodate different patients andcircumstances. Hole 130 should fit around the body extremity such as toprevent the antiseptic solution from escaping application bag 110 whenin use.

FIG. 2 shows another preferred embodiment of solution applicator 200.Solution applicator 200 includes application bag 210 which has largerdimensions to accommodate a larger appendage such as a leg. Patient'sappendage 240 is inserted into application bag 210 through opening 215toward closed end 213. This embodiment includes solution deploymentpouch 220 and a different closing means.

Application bag 210 is secured around patient's appendage 240 throughthe use of closing means 230. Some examples of closing means include anelastic band, adhesive tape or strap with a buckle or Velcro® closure. Apreferred embodiment includes strap with a Velcro® closure. Closingmeans 230 allows for securing and sealing application bag 210 aroundvarying size appendages and easy adjustment. Velcro® closure includeshook section 260 and receiver section 250 as necessary to use theclosing means 230 as described.

Closing means 230 is located between the opening 215 of application bag210 and the area to be treated with antiseptic, such that the area to betreated with antiseptic is contained within application bag 210. Closingmeans 230 can be attached to application bag 210 by commerciallyavailable adhesive or can be detachable.

Solution deployment pouch 220 is located on the interior of applicationbag 210 and contains the antiseptic to be deployed. Solution deploymentpouch 220 can vary in size and shape depending on the amount ofantiseptic solution contained. In the preferred embodiment, the solutiondeployment bag contains 2.5 liters of antiseptic solution. The solutiondeployment pouch may be color coded to indicate the type of antisepticcontained or may be metalized to prevent light from entering the pouchto the detriment of the antiseptic solution. In the preferredembodiment, the antiseptic to be deployed is chlorhexidine, sold underthe trademark ChloraPrep® and available from Medi-Flex, Inc. of Leawood,Kans. However, other antiseptics that are effective without evaporationcan also be employed.

FIG. 3A and FIG. 3B illustrate two preferred embodiments for solutiondeployment pouch 220. As shown in FIG. 3A, a cavity 305 is created onthe inside of application bag 300 by use of a cavity cover 310. Thecavity cover 310 in the preferred embodiment is a hemispherical flexiblecontainer heat welded around its circumference to the interior of theapplication bag. The size of cavity cover 310 will depend on the amountof antiseptic solution 320 to be contained. Cavity cover 310 is of suchstrength that cavity cover 310 can be ruptured for use but not duringnormal handling and storage of the application bag. Cavity cover 310 inthe preferred embodiment is formed from a 3 ml plastic sheet made ofHDPE. When cavity cover 310 is ruptured, antiseptic solution 320 locatedin the deployment pouch is released to the interior of the applicationbag.

FIG. 3B shows another preferred embodiment of solution deployment pouch220. Antiseptic solution 320 is encapsulated in capsule 330. Size andshape of capsule 330 will vary depending on the amount of antisepticsolution 320 contained. Capsule cover 340 forms the outer casing ofcapsule 330 and encapsulates antiseptic solution 320. Capsule 330, andthe encapsulated antiseptic 320, are attached to the inside ofapplication bag 300 by a known adhesive or spot welding. Capsulecovering 340 can be manufactured from commercially available plastics.In the preferred embodiment, the covering is HDPE and is about 3 mlthick. In another embodiment, the capsule can be a rigid but fracturalplastic capsule contained in a cylindrical form capable of being brokenfor use through a set of central perforations. Capsule 330 can beattached to application bag 300 at the time of shipment to the user orcould be sent separate from the application bag 300 and the userattaches capsule 330 at the time of use.

Multiple capsules or pouches can be used in a single application bagdepending on the decontamination method being addressed. Further,differing antiseptic solutions can be contained in different capsules.Furthermore, sterile sponges, brushes and swabs can be contained in thecapsule at the time of manufacture for use within the application bag toscrub the surgical site.

Referring now to FIG. 3C, a puncturing device is shown used in thepreferred embodiment of the invention which allows for easy puncturingof the deployment pouch and/or temperature monitoring. The surface ofthe deployment pouch is shown as 350. Fixed to the external surface ofdeployment pouch 350 is a rigid plastic rectangle 352. In the preferredembodiment, the dimensions of the plastic rectangle are approximately 10ml thick and formed of a rigid polystyrene. Other rigid plastics orlight metals such as aluminum can be used as well. Plastic rectangle 352includes halves 360 and 365 separated by a perforation 370. Perforation370 in the preferred embodiment traverses the rectangle in an angledfashion, including two pointed extensions 375 and 377.

In use, plastic rectangle 352 is broken along perforation 370 separatingthe two halves 360 and 365. Pointed extensions 377 and 375 are thenavailable to breach the surface of deployment pouch 350 thereby allowingthe antiseptic fluid contained to escape into the application bag. Theadvantage of the use of plastic rectangle 352 is to allow controlleddispersion of the antiseptic fluid and to allow a thicker and morerobust flexible plastic to be used for the deployment pouch.

In yet another embodiment, plastic rectangle 352 can include atemperature sensitive dye. The temperature sensitive dye can be used toindicate the temperature of the antiseptic contained in the deploymentpouch to allow for an accurate and effective dispensing temperature orfor patient comfort.

FIG. 4 shows yet another preferred embodiment of invention. Solutionapplicator 400 is application bag 410 with one end sealed and one endopen. Patient's appendage 495 is placed inside application bag 410through the open end.

In this embodiment, application bag 410 is closed around patient'sappendage 495 by use of pressure inflatable cuff 430. Pressureinflatable cuff 430 can be secured by any appropriate closing means 450and 460. Specifically, a preferred embodiment for such closing means 450and 460 is Velcro®, wherein closing means 450 is hook section andclosing means 460 is receiver section. Pressure inflatable cuff 430 islocated adjacent the open end of application bag 410. Pressure pump 480inflates pressure inflatable cuff 430 through tube 490. Pressure pump480 can be manually or mechanically inflated. Pressure inflatable cuff430 when inflated creates a seal sufficient to prevent the antisepticfrom escaping application bag 400.

FIG. 5 illustrates solution applicator 400 when pressure inflatable cuffis inflated.

FIG. 6 shows yet another preferred embodiment of solution applicator600. This embodiment can be employed when only a section of a patient'sappendage 650 is to be treated with antiseptic. In this embodiment,application bag 620 is open at both ends 652 and 654 and is tubular. Thelength of application bag 620 can vary depending on the size of the areabeing treated.

Each end of application bag 620 is closed around patient's appendage 650by use of closing means 630 and 632. Each closing means is similar tothose embodiments already described. For example, if Velcro® is used tosecure closing means 630 and 632, Velcro® closure includes hook sections640 and receiver sections 610 as necessary to use the closing means 630and 632 as described. Solution deployment pouch 220 is adhered to theinside of application bag 620 between the closing means on either end.

FIG. 7 illustrates solution applicator 600 after each end of applicationbag 620 has been closed around patient's appendage 650. The portion ofapplication bag 620 between closing means is loose-fitting aroundpatient's appendage 650. Solution deployment pouch 220 is ruptured andantiseptic fluid escapes to be massaged into the skin. All excessantiseptic is retained in the application bag 620 until closing means630 and 632 are released and application bag 620 is removed.

FIG. 8 shows a preferred embodiment of solution applicator 800. Solutionapplicator 800 can be used to apply antiseptic to a relatively flat areaof the body, such as the abdomen or back. Application bag 810 forms agenerally hemispherical shape placed over the surgical site. In thepreferred embodiment, application bag 810 allows a clearance of about 3inches when attached to the patient.

The circumference of application bag 810 is lined with a disk-likeadhesive strip 815. The adhesive strip is of sufficient tackiness toadhere to form a seal with the patient's skin, but still removablewithout injury. Suitable adhesives are well known in the art. The widthof the adhesive strip should range between ¼ inch and 1 inch. In thepreferred embodiment, a removable waxed tape covers the adhesive stripuntil such time as solution applicator will be applied to patient.Attached to the interior of application bag 810 is solution deploymentpouch 220 which contains antiseptic for treatment of the patient.Deployment and use of the antiseptic fluid is similar to that describedabove.

FIG. 9 illustrates a side view of solution applicator 800 attached toabdomen of patient 850. After adhesive strip 840 is applied to the skinof the patient, the remainder of application bag 810 allows for user tomaneuver application bag 810 to rub or massage the antiseptic fluid overthe skin without removing adhesive strip 840 from the skin.

Referring to FIGS. 10A, 10B, 10C, and 10D, application bag 910 hasoutside surface 914 and inside surface 915. Application bag 910 furtherhas a plurality of holes 911, 912, and 913, to accommodate theattachment of a plurality of scrub brushes 900. Hole 911 is locatedgenerally at the anterior knee area. Holes 912 and 913 are located onopposite sides of the ankle area. Scrub brush 900 is attached to insidesurface 915 by an adhesive or welding means known in the art. Handle 902then protrudes through the holes 911, 912, and 913, extending pastoutside surface 914 to allow a user to move scrub brush 900 to scrub thepatient's skin without the user making contact with the patent's skin.

Referring to FIG. 10A, application bag 910 can include a multitude ofsealing means including one of, but not limited to, the aforementionedgasket 120 with hole 130, closing means 230 with hook section 260 andreceiver section 250, and elastic band 720.

Application bag 910 can include a multitude of antiseptic insertionmeans including one of, but not limited to, the aforementionedfill/drain port 140, solution pouch 220 including cavity 305 and capsule330, and plastic rectangle 352.

In a preferred embodiment, application bag 910 is shaped to generallymatch leg 960. In this embodiment, scrub brushes 900 are attached toapplication bag 910 at the anterior knee area and opposite sides of theankle. However, those skilled in the art will appreciate thatapplication bag 910 can be made in a multitude of shapes to generallymatch other extremities or adapted to fit a torso and scrub brushes 900can be attached to application bag 910 at any desired location.

In a preferred embodiment, application bag 910 is made of HDPE (highdensity polyethylene) which is typically translucent, but not fullytransparent. In other embodiments, the application bag can be made outof LDPE (low density polyethylene) and can be quite clear, but still nottotally transparent. In other embodiments, LLDP (linear low densitypolyethylene) can be employed where a higher structural rigidity isrequired by the cleaning process. Other flexible sheeting can be used solong as it is inert with respect to the antiseptic solution. Otherplastics can be used if complete transparency is required for variouscleaning processes. In other embodiments, the application bag can becolor coded to indicate different sizes, different antiseptics containedwithin the bag or the proper operating theater for the patient.

In another preferred embodiment, the interior and/or exterior ofapplication bag 910 can be textured to increase the effectiveness of theapplication of the antiseptic to the patient. If on the exterior of theapplication bag, the purpose of the texturing is to increase frictionbetween the hands of the user and the exterior of the application bag toaid in manipulation of the application bag during use. If on theinterior of the application bag, the textured surface is useful inscrubbing the surgical site to remove bacterial colonies by applying anincreased friction to the surgical site. In one embodiment, the texturedsurface may be used to scrub the surgical site and/or an area out of thereach of scrub brush 900. In one embodiment, the textured surface and,the surgical site or the out-of-reach area, has a higher frictioncoefficient than the interior surface and, the surgical site or theout-of-reach area. In one embodiment, the textured surface and the handsof the user has a higher friction coefficient than the exterior surfaceand the hands of the user. The harder the surgical site and/or theout-of-reach area is scrubbed with the textured surface, the higher thefriction applied to the surgical site and/or the out-of-reach and viceversa. Examples of textures can include a set of raised ribs, chevronpatterns, diamond patterns or random “crinkling” having a varyingthickness. Any raised pattern that extends from the interior or outsidesurface may be employed. Other plastics can be used if completetransparency is required for various cleaning processes. In otherembodiments, the application bag can be color coded to indicatedifferent sizes, different antiseptics contained within the bag or theproper operating theater for the patient.

In a preferred embodiment, application bag 910 can be formed from twoidentical or nearly-identical sized sheets. Both sheets will have thesame or nearly the same shape. All of the sides but one are sealed orfused by an adhesive or heat welding as known in the art, leaving theremaining side open. The flat format of the completed application bagincreases the ease of storage and/or deployment of the bag from acardboard box as known in the art. The shape also promotes economy ofmanufacture.

In another preferred embodiment, application bag 910 can be formed by aflexible tubular extrusion of plastic. After manufacture, the tube canthen be cut to shape. After being cut, ends are sealed or fused by knowninductive welding means leaving one end open.

In a preferred embodiment, the general circumference of application bag910 is at least 2 inches larger than the part of the body beingdecontaminated. The width of application bag 910 in a preferredembodiment is usually between 2 inches and 40 inches. In the preferredembodiment, the general length of the application bag is at least 2inches longer than the part of the body being placed in application bag910. The length of application bag 910 in a preferred embodiment wouldbe between 2 inches and 60 inches. Application bag 910 should also allowfor complete articulation of any joint surrounded in order to allow forcomplete coverage by the antiseptic solution.

Referring to FIGS. 11A, 11B, 11C, and 11D, a preferred embodiment ofscrub brush 900 comprises brush 901, and rotatable handle 902. Brush 901includes bristles 903, which are attached to brush 901. Handle 902 isconnected to brush 901 at connection brackets 904, 905, 906, and 907.Pins 908 and 909 are inserted into connection bracket 904 and 906sliding through handle 902 into connection brackets 905 and 907.

Handle 902 can rotate about an axis adjacent to brush 901. Handle 902can be moved from position 950, which is generally perpendicular tobrush 901. Handle 902 can be moved in either direction 951 to rest onbrush 901 at position 953, which is adjacent to brush 901.Alternatively, brush 902 can be moved in direction 952 to position 954,which is adjacent to brush 901.

In a preferred embodiment, brush 901 and handle 902 are constructed of atransparent plastic. Bristles 903 are also constructed of a flexibleplastic. It will be appreciated by those skilled in the art that amultitude of transparent and durable materials may be substituted forthe construction of scrub brush 900 so long as it is inert with respectto the antiseptic solution.

In a preferred embodiment, scrub brush 900 is attached to applicationbag 910 in each of holes 911, 912 and 913 with an adhesive or weldingmeans known in the art. The adhesive is applied to form a seal aroundeach scrub brush and each hole.

In use, application bag 910 including an antiseptic insertion means israised to a temperature approximately equal to that of the patient. Anindication of the proper temperature is shown by the color of theplastic rectangle included on the deployment pouch. The application bagis extended and placed around the surgical site. In a preferredembodiment, application bag 910 is secured around the proximal end ofthe extremity. The distal end of the extremity resides in the interiorof the application bag.

The antiseptic is introduced into application bag 910 through antisepticinsertion means 140, 220, or 352. The exterior of the application bag isthen manipulated to assure coverage of the appendage by the antisepticfluid. The antiseptic fluid is then rubbed or massaged into the skinthrough application bag 910 to dislodge biological communities. Scrubbrush 900 and/or application bag 910 is manipulated to scrub the skin todislodge bacterial colonies. Excess antiseptic fluid is retained byapplication bag 910. Since application bag 910 is transparent orsubstantially transparent, a visual examination of the extremity isconducted to assure that adequate and complete coverage of the surgicalsite has been made.

Upon removal of application bag 910, care must be taken to ensure thatany portion of the non-sterile exterior of application bag 910 does notcome into contact with the now sterile extremity of the patient. Toaccomplish removal without contact, gasket 120, closing means 230, orelastic band 720 is rolled back so that only its sterile interior isadjacent the extremity. Application bag 910 is then removed by slidingit off of the extremity, making sure that the rolled back edge is theonly point of contact.

FIGS. 12A and 12B show a preferred embodiment of solution applicator1200. Solution applicator 1200 comprises two releasably joinable halvesconnected to a flexible gasket.

Referring to FIGS. 12A and 12B, application bag 1210 is comprised offirst portion 1212 and second portion 1214. First portion 1212 andsecond portion 1214 may be equally sized, separate halves or firstportion 1212 and second portion 1214 may be formed from a single sheetfolded on one edge. An end of first portion 1212 and an end of secondportion 1214 are each fused or sealed to gasket 1220 through a knownadhesive, tape, or heat welding to ensure a sealed attachment. Firstportion 1212 is attached to gasket 1220 at attachment area 1222 andsecond portion 1214 is attached to gasket 1220 at attachment area 1224.The shape of the attachment areas are generally semicircular, but othershapes are possible. Attachment areas 1222 and 1224 converge at points1223 and 1225 thus a complete seal to gasket 1220 is achieved. Firstportion 1212 includes tab 1232 and second portion 1214 includes tab1234.

Gasket 1220 can be manufactured from synthetic rubber, such as neopreneor nitrile, or a resilient plastic polymer. The gasket color can becoded to indicate the size and/or shape of the bag making for easy anderror free deployment of the antiseptic solution.

Gasket 1220 is generally flat and circular shaped, however oval andpolygonal shapes would suffice. Gasket 1220 has edge 1221 along theperimeter of gasket 1220 and hole 1230 in the relative center of gasket1220. In a preferred embodiment, diameter of hole 1230 ranges betweenabout 1 inch and 15 inches. However, those skilled in the art willrecognize that other sizes can be provided to accommodate differentpatients and circumstances. Hole 1230 should fit around a body extremitysuch as to prevent the antiseptic solution from escaping application bag1210 when in use. Attachment areas 1222 and 1224 are located betweenhole 1230 and perimeter 1221.

Attached to first portion 1212, second portion 1214, or both isfastening means 1236. Fastening means 1236 releasably attaches firstportion 1212 to second portion 1214 to form application bag 1210.Fastening means 1236 can be any releasable fastening means that is“watertight” such that the antiseptic introduced into application bag1210 remains inside application bag 1210 when the first portion isfastened to the second portion. Fastening means 1236 can include, but isnot limited to, releasable adhesive or a plastic zipper similar toZiplock®.

Application bag 1210 can include a multitude of antiseptic insertionmeans including one of, but not limited to, the aforementionedfill/drain port 140, solution pouch 220 including cavity 305 and capsule330, and plastic rectangle 352. Additionally, instead of gasket 1220,application bag 1210 may incorporate elastic band 720 or closing means230 with hook section 260 and receiver section 250. The interior and/orexterior surfaces of application bag 1210 may be textured and/or includea brush or other high friction scrubber.

Referring now to FIG. 13, the steps for use of application bag 1210 areshown. At step 1302, first portion 1212 is joined to second portion 1214with fastening means 1236. Fastening means 1236 provides a watertightseal. At step 1304, appendage 150 is inserted into application bag 1210through hole 1230 in gasket 1220. Appendage may be inserted through hole1230 after fastening first portion 1212 to second portion 1214 or firstportion 1212 may be fastened to second portion 1214 after appendage 150passes through hole 1230. At step 1306, gasket 1220 secures a sealbetween application bag 1210 and appendage 150.

Once first portion 1212 is fastened to second portion 1214, at step1308, antiseptic fluid is introduced to the interior of application bag1210 through antiseptic insertion means 140, 220, or 352. At step 1310,application bag 1210 is manipulated to apply the antiseptic fluid to theappendage and to dislodge bacterial colonies.

After sterilizing the appendage with the antiseptic fluid, at step 1312,the excess antiseptic fluid is drained through fill/drain port 140 or byseparating the first portion from the second portion without disturbingthe appendage. At step 1314, if not previously separated, first portion1212 is separated from second portion 1214. To separate the firstportion from the second portion, tab 1232 is peeled away from tab 1234such that first portion 1212 is unfastened from second portion 1214.With the appendage sterilized and exposed, gasket 1220 may remain inplace while physicians move forward with surgery on the appendage. Postsurgery, application bag 1210 may be reassembled to protect the surgicalsite from bacteria before transferring the patient from the surgicalenvironment to the recovery area.

Those skilled in the art will recognize that a more complete applicationof antiseptic fluid can be made due to the fact that application takesplace outside the operating theater. Those skilled in the art will alsorecognize that the antiseptic can be retained on the surgical arealonger, promoting a more thorough decontamination. Those skilled in theart will also recognize that since the decontamination can take placeoutside the operating theater that substantial operating theater timecan be saved with resulting monetary savings to the patient and thehospital.

A bacterial load comparison of standard operating room sterilizationtechniques versus use of a surgical preparation solution applicator bagfor preparing a patient's skin for surgery prior to entering thesurgical theater as disclosed herein was performed A summary of theresults are presented here.

The bacterial load comparison utilized a standard skin-swabbing followedby inoculation and agar plating approach to quantify the bacterial loadbefore and after sterilization. In total, 60 skin-swab samples werecollected for processing and 27 were used for final analysis.

For collection of swabbing, a single person served as their own control.Per person, left and right arms were swabbed individually and collectedin tubes. Then one arm was sterilized with standard operating roomsterilization techniques while the other arm was sterilized using thedisclosed surgical preparation solution applicator bag. Both arms werethen individually swabbed again and collected in individual tubesresulting in four samples per person.

Samples were plated without dilution on three Petri dishes containingBrain-heart infusion agar (Difco) supplemented by defibrinated horseblood (BAP-medium), thus providing a triplicate count per sample. Theplates were incubated at 30° C. and the resulting colonies were countedat 48 hours and 72 hours post-platting. This specific Petri dish mediumwas selected because it supports the growth of most common skin bacteriaand particularly those bacteria that can cause wound infections (e.g.,enterics, Staphylococcus and Streptococcus spp., Pseudomonasaeruginosa).

Following colony counting, six samples were removed from furtherconsideration due to spreading fungal growth. The presence of fungi onthe Petri dishes does not necessarily indicate contamination fromsampling or plating. Fungi may have been present on the skin of sampledindividuals. The medium used in the study was designed for countingbacteria, specifically because (1) bacterial count was the focus of thestudy and (2) bacteria are expected to be the main component of skinmicroflora. Moreover, counting of fungal colonies was not possible duethe exceedingly fast growth rate of fungal colonies on medium. The studydid not attempt to quantify fungal load and accordingly samplesdisplaying fungal growth were excluded from the study.

Other samples contained no bacterial growth or on average less than onebacterium per Petri dish replicate. For these samples, both left andright arms and three replicates from each arm produced identical numbers(i.e., a lack of bacterial growth) suggesting that a lack of bacteria isnot associated with sampling or plating errors but rather the lack of aculturable bacterial load on the skin of these subjects.

Additional samples yielded one or more Petri dishes with confluentcolonies and were assigned with “Too numerous to count” designation. Thenumber of plated bacteria for these samples exceeded 1,000 which isconsidered an upper limit of colonies that can be counted on onestandard Petri dish. Accordingly, the twenty seven remaining sampleswith two to three replicates each were selected for further statisticalanalyses.

Qualitatively, both sterilization techniques performed superbly byremoving almost all bacteria in the samples. For the standard technique,an average number of colonies recovered was 0.05 per plate. For thesurgical preparation solution applicator bag disclosed herein, theaverage number of colonies recovered was 0.012 colonies per plate. Apaired t-test was used to compare the number of colonies grown in aPetri dish from samples collected after the sterilant treatment of anindividual to the number of colonies grown in a control Petri dish fromthe same individual.

The resulting t(78 degrees of freedom)=1.778172 and p=0.039636. Thus,the result is significant at p≤0.05. When p<0.05, “the magnitude of theeffect” becomes of interest. The observed mean difference of 8.67±4.88suggests that on average the disclosed surgical preparation solutionapplicator bag killed 8.67 more bacteria/per plate in this study thanthe standard sterilization techniques. Although, the mean difference canbe explained by a systematic sampling error, the paired t-testdemonstrates that the surgical preparation solution applicator bagdisclosed herein is at least as good as the standard sterilizationtechniques commonly used in the operating theater.

In summary, the surgical preparation solution applicator bag disclosedherein demonstrated the efficiency of sterilization not worse than andpossibly better than that of standard techniques, essentially killingall bacteria on sampled skin areas.

The embodiments have been described in detail with particular referenceto certain preferred embodiments thereof, but it will be understood thatvariations and modifications can be effected within the scope of theembodiments, especially to those skilled in the art.

The invention claimed is:
 1. A containment device for deploying anantiseptic preparation to an extremity of a patient comprising: aflexible container, comprised of a first portion and a second portion,configured to surround the extremity; a fastening means, for theseparable and resealable attachment of the first portion to the secondportion, attached to the flexible container; a sealing means, fused tothe flexible container, capable of securing a seal between the extremityand an exterior of the flexible container; a sealable opening in theflexible container for introduction of the antiseptic preparation; and,whereby the antiseptic preparation is deployed into and contained withinthe flexible container.
 2. The containment device of claim 1, whereinthe fastening means is one from the group consisting of an adhesive anda zipper.
 3. The containment device of claim 1, wherein a set oftextures are formed on an interior surface of the flexible container. 4.The containment device of claim 1, wherein the flexible containerfurther comprises at least one high friction scrubber attached to aninterior surface of the flexible container.
 5. The containment device ofclaim 1, wherein the sealing means comprises: a flexible gasket having aperimeter and a hole within the perimeter; wherein the first portion andthe second portion are attached to the flexible gasket between theperimeter and the hole.
 6. The containment device of claim 5, whereinthe flexible gasket is color-coded to indicate a size of the flexiblecontainer.
 7. The containment device of claim 1, wherein the flexiblecontainer is color-coded to indicate a relationship between the patientand an operating theater.
 8. A device for applying an antiseptic to anextremity comprising: a manipulatable membrane, comprised of a firstportion releasably and resealably fastened to a second portion; aflexible seal fixed to the membrane; an antiseptic deployment pouch inthe membrane; and, whereby the antiseptic is deployably introducedinside the membrane and contained inside the membrane and removescontaminants from the extremity.
 9. The device of claim 8, wherein theantiseptic deployment pouch comprises a solution pouch and one or moreof a cavity in the manipulatable membrane, and a breakable releaseportal.
 10. The device of claim 8, wherein the first portion is fastenedto the second portion by at least one of an adhesive and a zipper. 11.The device of claim 8, further comprising an antiseptic temperatureindicator in heat conductive contact with the antiseptic to be applied.12. The device of claim 8, wherein the flexible seal is one from thegroup of a flexible gasket, an elastic band, and a fabric hook-and-loopfastening band.
 13. The device of claim 8, wherein an interior surfaceof the membrane includes at least one from the group of a texturedsurface and a brush.
 14. A containment device for deploying anantiseptic preparation to an extremity of a patient, comprising: aflexible container, comprised of a first portion and a second portion,configured to surround the extremity; a fastening means, for theseparable and resealable attachment of the first portion to the secondportion, attached to the flexible container; a sealing means, attachedto the flexible container, capable of securing a seal between theextremity and an exterior of the flexible container; a sealable openingin the flexible container for introduction of the antisepticpreparation; whereby the antiseptic preparation is deployed into andcontained within the flexible container; wherein the flexible containerfurther comprises at least one high friction scrubber attached to aninterior surface of the flexible container; wherein the at least onehigh friction scrubber comprises a brush, having a plurality ofbristles; and, wherein a handle is connected to the brush.
 15. Acontainment device for deploying an antiseptic preparation to anextremity of a patient, comprising: a flexible container, comprised of afirst portion and a second portion, configured to surround theextremity; a fastening means, for the separable and resealableattachment of the first portion to the second portion, attached to theflexible container; a sealing means, attached to the flexible container,capable of securing a seal between the extremity and an exterior of theflexible container; a sealable opening in the flexible container forintroduction of the antiseptic preparation; whereby the antisepticpreparation is deployed into and contained within the flexiblecontainer; and, wherein the sealable opening is a semi rigid ring sealedby a matching and removable plug.
 16. A device for applying anantiseptic to an extremity, comprising: a manipulatable membrane,comprised of a first portion releasably and resealably fastened to asecond portion; a flexible seal attached to the membrane; an antisepticinsertion means in the membrane; whereby the antiseptic is introducedinto and contained inside the membrane and removes contaminants from theextremity; and, wherein the antiseptic insertion means includes anopening and a cap securable within the opening forming a resealableport.
 17. In a device for the surgical preparation of an extremity of apatient comprising a flexible container comprised of a first portionreleasably attached to a second portion, a gasket attached to theflexible container, and at least one of an antiseptic deployment pouch,capsule, and cavity cover in the flexible container, a method comprisingthe steps of: attaching the first portion to the second portion;inserting the extremity into the flexible container; securing a sealbetween the flexible container and the extremity with the gasket;introducing an antiseptic fluid with the at least one of the antisepticdeployment pouch, capsule, and cavity cover; dispensing the antisepticfluid by manipulating an outside surface of the flexible container; and,manipulating the flexible container to apply the antiseptic fluid to theextremity.
 18. The method of claim 17, further comprising: draining theantiseptic fluid from the flexible container; and, separating the firstportion from the second portion.
 19. In a device for the surgicalpreparation of an extremity of a patient comprising a flexible containercomprised of a first portion releasably attached to a second portion, agasket attached to the flexible container, and an antisepticintroduction means in the flexible container, a method comprising thesteps of: attaching the first portion to the second portion; insertingthe extremity into the flexible container; securing a seal between theflexible container and the extremity with the gasket introducing anantiseptic fluid with the antiseptic introduction means; manipulatingthe flexible container to apply the antiseptic fluid to the extremity;providing a friction surface attached to an interior surface of theflexible container; and, manually scrubbing the extremity with thefriction surface to remove bacterial colonies.